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Sodium Oxybate Promising Treatment For Narcolepsy
A DGReview of :"A 12-month, Open-Label, Multicenter Extension Trial of Orally Administered Sodium Oxybate for the Treatment of Narcolepsy"
Sleep
03/04/2003
By Veronica Rose
Sodium oxybate appears to be a safe and effective treatment for narcolepsy, say American researchers.
One hundred and eighteen patients with narcolepsy participated in a 12-month, open-label, multi-centre evaluation of long-term safety and efficacy of nightly sodium oxybate. The patients had previously participated in a 4-week double-blind trial of the same medication.
They received sodium oxybate 6g nightly, in equally divided doses at bedtime and again 2.5 to 4 hours later. Dosage was either increased or decreased incrementally by 1.5-g at 2-week intervals accordingly to either efficacy or adverse effects, but staying within a range of 3 to 9 g nightly.
Symptoms of narcolepsy and adverse events were recorded in daily diaries. Physical and laboratory examinations were repeated at 6 and 12 months, and maintained as safety measures. Primary efficacy measures noted any alteration in weekly cataplexy attacks from baseline.
The Epworth Sleepiness Scale measured secondary effects including daytime sleepiness, unexpected naps, sleep attacks or nocturnal awakenings. Researchers then rated the changes in the degree of disease severity.
There were noticeable overall improvements in the symptoms of narcolepsy after four weeks administration of sodium oxybate 3 to 9 g nightly, and were maximal after eight weeks. The researchers noted that the improvements included significantly decreased frequency in the attacks of cataplexy.
Daytime sleepiness diminished, and patients reported an improvement in the quality of nocturnal sleep, a higher degree of alertness and ability to concentrate.
The researchers concluded adverse events were mild and there were no indications of patient tolerance for sodium oxybate.
Sleep January 2003;26:1:31-35.
"A 12-month, Open-Label, Multicenter Extension Trial of Orally Administered Sodium Oxybate for the Treatment of Narcolepsy"
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